Camtech Rapid Antigen Test Kit

• Direct viral protein detection from nasal, oro-, or nasohopharyngeal swab specimens
• Results in less than 20 minutes including sample collection time
• Early detection of COVID-19 cases – Reliable identification of SARS-CoV-2 viral particles within the first week of the onset of symptoms or in certain asymptomatic cases.
• Clinical studies carried out on several continents validated the high sensitivity and specificity of the antigen kit
• Users and validation studies indicate that the kit works across all variants, especially Alpha, Delta, and Omicron

 Background and intended use of Covid rapid antigen test kit

The Camtech COVID-19 Antigen Rapid Test Kit is intended for the qualitative detection of the SARS-CoV-2 antigen in human anterior nares (nasal) swab samples in vitro from individuals within the first seven days of symptom onset. The fast testing procedure, high sensitivity, and simple operation make this rapid test kit a preferred method to detect acute cases of COVID-19, caused by SARS-CoV-2 infection. This kit cannot be used as a sole basis for the diagnosis and exclusion of pneumonitis patients infected by the SARS-CoV-2. 

Based on the current epidemiological investigation, the incubation period of COVID-19 is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are found in a few cases.

  How to Use the Covid Rapid Antigen test kit

Sample collection and preparation

• The Camtech COVID-19 Antigen Rapid Test should be performed using nasal (anterior nares) specimens.
• Take out the test card and other provided materials and lay them on the table to prepare for use. Perform the test at room temperature and 30%-50% humidity. Avoid heavily ventilated environments.
• Collect nasal (anterior nares) swab samples:
  • Remove the swab from the container, being careful not to touch the soft end, which is the absorbent tip.
  • Insert the entire absorbent tip of the swab into the nostril, but do not insert the swab more than ¾ of an inch (1.5 cm) into the nose.
  • Slowly rotate the swab in a circular path against the inside of the nostril at least 4 times for a total of 15 seconds. Be sure to collect any nasal drainage that may be present on the swab.
  • Gently remove the swab.
  • Using the same swab, repeat steps b) to d) in the other nostril.
  • The specimen is now ready for preparation using the buffer solution.

The test procedure for the Covid Antigen Rapid test kit

• Remove the cover of the buffer solution without squeezing the tube.
• Insert the swab with the collected specimen into the tube and wait approximately one minute.
• Remove the test cassette from the foil pouch and place the test cassette on a flat and clean surface.
• Dip the swab repeatedly into the tube 8-10 times and stir the swab vigorously inside the buffer tube (approximately 10 seconds).
• Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
• Close the buffer tube with the dropper cap securely. Mix thoroughly by turning or flicking the bottom of the tube five times.
• Add 4 drops (~100 μl) of the processed specimen by inverting the buffer tube and gently squeezing out the liquid into the Sample well of the test card. Keep the dropper tip pointing downwards and hold it vertically.
• Wait for 15 minutes before interpreting the test results. Do not read the results after 20 minutes of testing.

 Result in Interpretation of Covid Antigen Rapid test kit

Positive result: if both the quality control line (C) and the detection line (T) appear, the SARS-CoV-2 antigen has been detected and the result is positive. The result is considered positive even if a faint detection line (T) appears.	Negative result: if there is only a quality control line (C) and the detection line (T) is colorless, that indicates that the SARS-CoV-2 antigen has not been detected and the result is negative.	Invalid result: if the quality control line (C) is not observed, the test is invalid regardless of whether or not there is a detection line (T). Repeat the test with another test device.

  Precautions while using Covid Antigen Rapid test kit

• Failure to follow the test procedure may adversely affect test performance and/or invalidate the test result.
• Sample collection and processing methods have a great impact on virus detection. Negative test results do not exclude the possibility of virus infection. If the test result is negative and the patient has clinical symptoms, it is recommended to use virus isolation and culture for confirmation, and a comprehensive diagnosis by the attending physician.
• Negative test result may occur if the level of antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly
• Do not use visually bloody or viscous samples to obtain accurate results.
• The collected samples may be contagious, and the processing and testing operations of the samples should be performed in compliance with local relevant biosafety regulations.
• Due to the relatively high (90.76%) sequence homology between the nucleocapsid protein of SARS-CoV and SARS-CoV-2, the test might not differentiate between these two viruses.
• Please test the swab samples collected on-site, and do not test samples intended for RT-PCR (e.g. in VTM or UTM media.).
• Please use the kit’s matching swab and the provided buffer solution for sample collection and extraction, respectively. Do not use any other type of swab or different buffer solution.
• The test card should be neat and unbroken without any damage, burrs, or dust; the card should be firmly held together.
• It is normal if the sample does not flush immediately after being added to the sample well. Do not try to tilt the cassette, wait for it to flow instead.